Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor.
Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.
Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.
In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.
Various treatments have been used to address these and other pelvic ailments. For example, implantable surgical meshes have been used for hernia repair and pelvic floor tissue repair. Urethral slings have been used for treating fecal and urinary incontinence. and many others. Other treatments involve the use of bulking agents and tissue adhesives.
There is a desire for improved compositions and systems for the treatments of pelvic floor disorders. Challenges in this area of technology include maintaining proper positioning of an implant following placement and improving tissue healing in the implant area. The invention provides improved compositions and systems for the treatment of pelvic floor disorders using silk fibroin-containing hydrogel compositions.